Elucid Wins FDA Clearance for FFR-IQ Heart Imaging Software

Boston, Massachusetts, United States, October 21, 2026

FFR-IQ Combines Coronary Anatomy and Plaque Biology

FFR-IQ analyzes previously acquired coronary CT angiography images using AI-enabled algorithms to generate CT-derived fractional flow reserve (FFR-CT) estimates. Fractional flow reserve is a physiological measurement used to determine whether a narrowing in a coronary artery significantly restricts blood flow to the heart muscle. Traditionally, invasive FFR measurement involves cardiac catheterization and a pressure wire placed inside the coronary artery. Elucid’s software is designed to estimate this physiological information noninvasively from CT imaging data, potentially helping clinicians assess the functional significance of coronary lesions before deciding whether invasive evaluation is appropriate. Unlike approaches that focus primarily on the anatomical degree of narrowing, BioIntegrated FFR-CT incorporates plaque composition alongside coronary anatomy when estimating physiological impact. This approach is intended to provide additional information about the characteristics of atherosclerotic disease and how they may influence coronary blood flow. The software is intended to be used by qualified clinicians alongside patient history, symptoms, other diagnostic tests and professional medical judgment.

ELUCIDATE Study Reports Diagnostic Performance

The FDA clearance was supported by findings from the ELUCIDATE FFR-CT study, which evaluated the performance of FFR-IQ against invasive FFR measurements. According to Elucid, the study demonstrated 92.2% sensitivity and 93.1% specificity for the software’s noninvasive FFR estimation. Sensitivity measures how effectively a test identifies cases with the target condition, while specificity measures how effectively it identifies cases without that condition, according to the study’s reference standard. These results provide evidence supporting the software’s diagnostic performance in the evaluated population. Elucid has described the reported results as demonstrating high performance among FFR-CT validation studies. However, these figures should be interpreted in the context of the study design, patient population and comparison method rather than as a guarantee of performance in every clinical setting. The company announced that detailed results from ELUCIDATE were scheduled to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego on November 1, 2026. Further examination of the study findings may help clinicians and researchers understand how plaque-informed physiological assessment could contribute to coronary artery disease evaluation.

Elucid Integrates FFR-IQ With Plaque-IQ Technology

Elucid also plans to bring FFR-IQ together with its FDA-cleared Plaque-IQ software in a broader clinical platform. Plaque-IQ evaluates coronary plaque burden and composition from CT images, including features such as lipid-rich necrotic core, which is associated with atherosclerotic plaque characteristics. Combining the two technologies is intended to provide clinicians with information about coronary anatomy, plaque biology and estimated physiology from a single CCTA examination, supported by an integrated interface and reporting workflow. This combined approach could help clinicians consider both the severity of an arterial narrowing and the underlying characteristics of the plaque when assessing cardiovascular risk and planning care. For patients with suspected coronary artery disease, noninvasive physiological estimates may help inform decisions about whether additional invasive assessment or revascularization should be considered. Nevertheless, FFR-IQ is a clinical decision-support tool, and its results do not replace comprehensive medical evaluation or independent clinical judgment. The company announced commercial availability of FFR-IQ alongside its FDA clearance, providing a new option for healthcare facilities seeking AI-supported coronary imaging analysis. The technology’s real-world contribution will depend on clinical implementation, interpretation of results and evidence from continued use. Elucid’s FDA clearance of FFR-IQ represents a further development in AI-enabled cardiovascular diagnostics. By combining anatomical and plaque-related information with noninvasive estimates of coronary physiology, the company aims to support more comprehensive assessment of coronary artery disease and more personalized treatment decisions. The technology adds to the evolving role of medical imaging software in cardiovascular care, where advanced analysis may help clinicians move beyond anatomical imaging alone when evaluating patients.

Source: Elucid press release